Unrestricted Rehabilitation Pathway Following Total Hip Replacement

Total Hip Replacement Clinical Trial

— ReHip2  

Official title:

A Randomised Controlled Trial of the Impact on Function of an Unrestricted Rehabilitation Pathway of no Precautions Following Total Hip Replacement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03833258
• Other study ID #: NHS001514
• Status: Terminated
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: November 2022
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of ReHip2 is to explore the impact on function and quality of life in patients following Total Hip Replacement (THR). A randomised controlled trial will compare two different rehabilitation pathways following surgery (Routine care with precautions and Treatment group with no precautions). The proposal is to carry out the RCT with a minimum of 182 patients based in the UK.

Description:

Dislocation of the hip following total hip replacement (THR) is the sole reason for the endorsement of precautions following THR. This has remained unchanged sine the first hip replacement in 1969.

The precautions are;

• Patients must not bend past 90 degrees at the hip (including sitting)

• Patients must not twist in either standing or sitting

• Patients must partial weight bear with elbow crutches for a minimum of 6 weeks

• Patients must sleep on their back for a minimum of 6 weeks

• Patients must not cross their legs

Studies exploring factors affecting dislocation following THR identified three main influences: surgical technique, type of prosthesis and post-operative precautions. A number of studies have challenged the continued use of precautions or explored their impact on dislocation. However, these studies did not fully consider the impact of all precautions on dislocation, choosing to only select elements of the precautions for investigation. A recent review concluded the evidence evaluating practice and the impact of precautions was of poor quality. The review suggested further research should take into account different surgical approaches, different femoral head sizes and the type of prosthesis. Although there are studies that explored some of these hip dislocation confounders, the true impact of precautions remains unknown.

Whilst precautions continue to be endorsed by surgeons and other clinicians, previous challenges have raised awareness of the possible excessiveness of precautions and the importance of further robust work recommended. This is particularly so in the wake of developments in surgical technique and prostheses design, such as hip joint capsule repair and larger femoral head sizes (larger hip replacements). These developments and their impact on dislocation are beginning to cast doubt on the impact of post-operative precautions and their direct link to incidence of dislocation, which is their primary purpose.

The imposition of precautions has been evidenced to impact on both function and quality of life, with resultant non adherence in a proportion of patients. This study intends to explore whether an unrestricted pathway has no worse outcome in function, pain and quality of life parameters, in two specialist units in a multi-centre, prospective, randomised, non-inferiority study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants over the age of 18 years will be included.

• All participants should be proceeding with routine care unilateral (one side only) primary THR for treatment of osteoarthritis

• The patients operating consultant agreed to involvement of their patients in the study.

• All subjects assessed during routine pre-operative assessment in their respective hospital will have been assigned an American Society of Anesthesiologists (ASA) up to grade 3 out of a total of 6 (defined as 'severe systemic disease that limits activity but is not incapacitating').

• Patients who have undergone previous hip injection for treatment of osteoarthritic symptoms.

• All surgical approaches (anterior, lateral and posterior), cemented and un-cemented prostheses and all size femoral head size.

Exclusion Criteria:

• The operating consultant declined participation in the study.

• The participant previously had hip surgery to the same hip, including arthroscopy, revision hip surgery or treatment for Avascular Necrosis.

• ASA grade 4 or above 'A patient with severe systemic disease that is a constant threat to life.'

• Patients with specifically identified increased risk of dislocation (for example neuromuscular disease, hypermobility)

• Complex primary hip replacement (THR with femoral osteotomy or structural bone grafting / augmentation of acetabulum)

• Patients unable to complete the postal outcome measures.

• Any patient with pre-operative cognitive impairment (Dementia or Learning disabilities).

• Patients undergoing THR for treatment of fractured neck of femur.

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Behavioral:
• Rehabilitation with no precautions
Patients will recover from total hip replacement surgery being guided by pain only and not by the precautions imposed upon them by clinicians.

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester
United Kingdom	Wrightington Wigan and Leigh NHS Foundation Trust	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (33)

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Barnsley L, Barnsley L, Page R. Are Hip Precautions Necessary Post Total Hip Arthroplasty? A Systematic Review. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):230-5. doi: 10.1177/2151458515584640. — View Citation

Berry DJ, von Knoch M, Schleck CD, Harmsen WS. Effect of femoral head diameter and operative approach on risk of dislocation after primary total hip arthroplasty. J Bone Joint Surg Am. 2005 Nov;87(11):2456-63. — View Citation

Berry DJ, von Knoch M, Schleck CD, Harmsen WS. The cumulative long-term risk of dislocation after primary Charnley total hip arthroplasty. J Bone Joint Surg Am. 2004 Jan;86(1):9-14. — View Citation

Blom AW, Rogers M, Taylor AH, Pattison G, Whitehouse S, Bannister GC. Dislocation following total hip replacement: the Avon Orthopaedic Centre experience. Ann R Coll Surg Engl. 2008 Nov;90(8):658-62. doi: 10.1308/003588408X318156. Epub 2008 Sep 30. — View Citation

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Conner-Spady BL, Marshall DA, Bohm E, Dunbar MJ, Noseworthy TW. Comparing the validity and responsiveness of the EQ-5D-5L to the Oxford hip and knee scores and SF-12 in osteoarthritis patients 1 year following total joint replacement. Qual Life Res. 2018 May;27(5):1311-1322. doi: 10.1007/s11136-018-1808-5. Epub 2018 Feb 8. — View Citation

Cummins JS, Weinstein JN. The role of patient restrictions in reducing the prevalence of early dislocation following total hip arthroplasty. J Bone Joint Surg Am. 2005 Nov;87(11):2587; author reply 2587-8. — View Citation

Duwelius PJ, Burkhart RL, Hayhurst JO, Moller H, Butler JB. Comparison of the 2-incision and mini-incision posterior total hip arthroplasty technique: a retrospective match-pair controlled study. J Arthroplasty. 2007 Jan;22(1):48-56. — View Citation

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Forster FJ. Relaxing hip precautions increased patient satisfaction and promoted quicker return to normal activities after total hip arthroplasty. Evid Based Nurs. 2005 Oct;8(4):115. — View Citation

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Jørgensen CC, Kjaersgaard-Andersen P, Solgaard S, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Hip dislocations after 2,734 elective unilateral fast-track total hip arthroplasties: incidence, circumstances and predisposing factors. Arch Orthop Trauma Surg. 2014 Nov;134(11):1615-22. doi: 10.1007/s00402-014-2051-3. Epub 2014 Aug 14. — View Citation

Krotenberg R, Stitik T, Johnston MV. Incidence of dislocation following hip arthroplasty for patients in the rehabilitation setting. Am J Phys Med Rehabil. 1995 Nov-Dec;74(6):444-7. — View Citation

Masaoka T, Yamamoto K, Shishido T, Katori Y, Mizoue T, Shirasu H, Nunoda D. Study of hip joint dislocation after total hip arthroplasty. Int Orthop. 2006 Feb;30(1):26-30. Epub 2005 Dec 13. — View Citation

Mikkelsen LR, Petersen MK, Søballe K, Mikkelsen S, Mechlenburg I. Does reduced movement restrictions and use of assistive devices affect rehabilitation outcome after total hip replacement? A non-randomized, controlled study. Eur J Phys Rehabil Med. 2014 Aug;50(4):383-93. Epub 2014 Jan 30. — View Citation

Peak EL, Parvizi J, Ciminiello M, Purtill JJ, Sharkey PF, Hozack WJ, Rothman RH. The role of patient restrictions in reducing the prevalence of early dislocation following total hip arthroplasty. A randomized, prospective study. J Bone Joint Surg Am. 2005 Feb;87(2):247-53. — View Citation

Restrepo C, Mortazavi SM, Brothers J, Parvizi J, Rothman RH. Hip dislocation: are hip precautions necessary in anterior approaches? Clin Orthop Relat Res. 2011 Feb;469(2):417-22. doi: 10.1007/s11999-010-1668-y. — View Citation

Schmidt-Braekling T, Waldstein W, Akalin E, Benavente P, Frykberg B, Boettner F. Minimal invasive posterior total hip arthroplasty: are 6 weeks of hip precautions really necessary? Arch Orthop Trauma Surg. 2015 Feb;135(2):271-274. doi: 10.1007/s00402-014-2146-x. Epub 2015 Jan 4. — View Citation

Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10. Review. — View Citation

Smith TO, Jepson P, Beswick A, Sands G, Drummond A, Davis ET, Sackley CM. Assistive devices, hip precautions, environmental modifications and training to prevent dislocation and improve function after hip arthroplasty. Cochrane Database Syst Rev. 2016 Jul 4;7:CD010815. doi: 10.1002/14651858.CD010815.pub2. Review. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Hip Score (OHS)	Consists of 12 items measuring pain, activity, joint mobility and ambulatory activity using a 5 point ordinal Likert Scale over the previous 4 weeks. The total score for the OHS range from 12-60 with the lowest score of 12 signifying the least limited function and the highest score of 60 signifying the most limited function.	assessed at baseline, 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is an outcome measure designed to assess sleep quality, disturbance and impact on function over the preceding one month. The PSQI measures seven categories. Scores total greater than 5 indicate clinically meaningfully disturbed sleep or poor sleep, less than 4 indicates no problems with sleep	assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery
Secondary	EQ-5D-L	The lowest score of 0 indicates no functional impairment and a score of 4 indicates significant impairment. The category responses are not combined.; Using a continuous scale on a 20cm vertical visual analogue scale (VAS) a score of 100 means 'the best health imaginable and a score of 0 means 'the worst health imaginable.' EQ5DL Scores at different timepoints are compared to show changes in health over time	assessed at baseline 6 and 12 weeks after total hip replacement to assess change at each time point following surgery